ISO 11608-5:2022 PDF

Scope: This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO). General requirements are provided for all automated functions. In addition, specific requirements are provided for the following automated functions: a) medicinal product preparation (e.g. reconstitution); b) needle preparation; c) needle hiding; d) priming; e) dose setting; f) needle insertion; g) injection depth control; h) injection of the medicinal product; i) recording of device functions; NOTE This document does not cover remote communication from the NIS-AUTO (pertains to wired and wireless communication transfer from the NIS auto). j) disabling the NIS-AUTO; k) needle retraction; l) needle shielding; m) needle removal. All references to "function" in this document are by definition construed as automated functions (see 3.2). This document does not apply to functions that are performed manually by the user.

ISO 11608-5:2022 Referenced Document

ISO 11608-1:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
ISO 11608-3:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

2022 ISO 11608-5:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
2012 ISO 11608-5:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions